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Study on HIV prevention pill halted after new infections

Monday April 18 2011

An Aids patient takes her daily dose of life-saving anti-retroviral (ARV) drugs. Patients who have been exposed to fake and poor quality HIV medicines may have to wait longer before they can know whether the products contained any harmful substances. File I Photo

An Aids patient takes her daily dose of life-saving anti-retroviral (ARV) drugs. Patients who have been exposed to fake and poor quality HIV medicines may have to wait longer before they can know whether the products contained any harmful substances. File I Photo 

By GATONYE GATHURA [email protected]

It was bad news for about 700 women in Bondo, Nyanza when a study testing whether a daily dose of a pill called Truvada can prevent HIV infection was discontinued.

A statement released on Monday by the Family Health International (FHI), a lead organisation in the trials, said interim data indicates the pill had not shown any effectiveness among study participants and hence is to be discontinued.

FHI advised the researchers to initiate an orderly closure of the study over the next few months.

By February, FHI estimated that only about five per cent of the study participants had acquired new HIV infections while about nine per cent on the drug had become pregnant.

This pregnancy rate was higher in participants on Truvada compared to those taking a placebo.

“Study participants who became infected with HIV during the study are being followed by the research team for an additional year and are referred for appropriate medical care and treatment in their community,” says the statement.

The new development has confounded researchers considering that a recent similar study had showed that use of Truvada can prevent infection in men who have sex with men from HIV infection.

FHI predicts that this may have been because of low adherence to study regimen, a true lack of effect of the product among women or other factors still to be determined.

“This is a very disappointing development since women have much higher rates of HIV infection compared to men. This would have been an effective tool to offer women some protection,” Dr Nicholas Muraguri, head of the National AIDS/STI Control Programme told the Nation on Monday.

As of February, the study had screened 3,752 women and enrolled 1,951: 739 in Bondo, Kenya; 764 in Pretoria, South Africa; 432 in Bloemfontein, South Africa; and 16 in Arusha, Tanzania.

Locally, the study was led by a team from the Kenya Medical Research Institute.